Statistical Optimization and Evaluation of Extended Release Tablets for Divalproex Sodium

Abstract

The purpose of current experimental research is to optimize the quantities of macromolecules such as EudragitL/100-55, HPMC-K-100M for the development of divalproex sodium extended release tablets. Divalproexsodium, an anticonvulsant or epileptic agent. It was used in the effective management of bipolar disorders, Mania, seizures, convulsions, tremors/epilepsy. Divalproex sodium ER tablets were formulated with the help of EudragitL/100-55 and HPMC-K-100M in variable composition and variable amounts as per 32 factorial design technique. They were prepared by direct compression technique. Quantities of polymers required for exhibiting extended release of active agent from tablet were chosen as independent variables, in the similar way time required for drug release were chosen as dependent variables (t10%,t50%,t75%,t90%,). Nine formulations were created in accordance with the plan, formulated, and tested for quality control criteria. It is obvious from the results that all formulations meet the compendial restrictions. In order to estimate the kinetic parameters, data from the dissolution research was effectively suited to kinetic modeling. For the responses, polynomial equations were created and validated. The optimised formulation SOD5, which contains 31.25 milligrams of EudragitL/100-55 and 31.25 milligrams of HPMC-K-100M, exhibits resemblance to the commercial product of f2=85.91 and f1=2.25 (DIVALEX). SOD5 formulation follows zero order, and a non-fickian type release mechanism was discovered (n = 0.645).